Vascular remodeling device

• US 9,089,332 B2
• Filed: 03/23/2012
• Issued: 07/28/2015
• Est. Priority Date: 03/25/2011
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Molaei, Masoud, Epstein, Evan David, Newell, Gabriel Francis Wilgus, Tran, Quang
• Primary Examiner(s): ANDERSON, GREGORY A
• Application Number:
  US13/428,237
• Publication Number:
  US 20120245675A1
• Time in Patent Office: 1,222 Days
• Field of Search: 623/1.15, 623/1.16, 623/1.18, 623/1.3, 623/23.72, 623/1.13, 623/1.35, 623/1.2, 606/191, 606/200, 606/213, 606/215, 606/216
• US Class Current: 1/1
• CPC Class Codes: A61B 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61F 2/07 Stent-grafts

Abstract

A vascular remodeling device is provided. The device has an anchor portion, sized for deployment in a blood vessel, that is radially expandable from a collapsed state to an expanded state. The device also includes a distal portion sized for deployment in a blood vessel. The distal portion is radially expandable from a collapsed state to an expanded state and has a distal face that is sufficiently occlusive in the distal-to-proximal direction to perform a therapeutic blocking function in an aneurysm neck. The device also has an intermediate portion that interconnects a distal end of the anchor portion and a proximal end of the distal portion. In some embodiments, the anchor portion and/or distal portion has a plurality of interconnected struts.

Claims

1. A vascular remodeling device, comprising:

a proximal portion radially expandable from a collapsed state to an expanded state such that, when expanded in a blood vessel, the proximal portion engages a wall of the vessel, the proximal portion having a first waist comprising a radially largest region of the proximal portion when in the expanded state;

a distal portion radially expandable from a collapsed state to an expanded state, the distal portion having a longitudinal axis and a second waist comprising a radially largest region of the distal portion when in the expanded state, the distal portion having a distal face located distal to the second waist; and

an intermediate portion that couples a distal end of the proximal portion and a proximal end of the distal portion, the intermediate portion comprising a radially narrowest region of the vascular remodeling device between the first and second waists of the proximal and distal portions;

wherein the proximal portion comprises a plurality of interconnected proximal struts that extend distally from a proximal end of the proximal portion such that (a) proximal to the first waist, the proximal struts each (i) diverge from the longitudinal axis and (ii) divide into at least two proximal sub-struts; and

(b) distal to the first waist, the proximal sub-struts each (i) merge with an adjacent proximal sub-strut, and (ii) converge toward the longitudinal axis, the proximal portion having a total number of proximal sub-struts that is at least double a total number of proximal struts;

wherein the distal portion comprises, between the proximal end of the distal portion and the second waist, only a plurality of distal struts that extend distally from the proximal end of the distal portion such that (a) distal to the second waist, the distal struts each (i) diverge from the longitudinal axis and (ii) divide into at least two distal sub-struts wholly distal to the second waist; and

(b) distal to the second waist, the distal sub-struts each (i) merge with an adjacent distal sub-strut, and (ii) converge toward the longitudinal axis, the distal portion having a total number of distal sub-struts that is double a total number of distal struts.

2. The vascular remodeling device of claim 1, wherein the distal struts are configured to maintain a three dimensional shape of the proximal portion.

3. The vascular remodeling device of claim 1, wherein the distal struts are configured to prevent the distal struts from aggregating toward a single side of the blood vessel.

4. The vascular remodeling device of claim 1, wherein the interconnected proximal struts are configured to structurally support each other.

5. The vascular remodeling device of claim 1, wherein each proximal strut extends from an origination junction and is divided into a first one and second one of the proximal sub-struts, wherein the first one of the proximal sub-struts is connected to a first adjacent strut and the second one of the proximal sub-struts is connected to a second adjacent strut.

6. The vascular remodeling device of claim 5, wherein a length of the first one of the proximal sub-struts and a length of the second one of the proximal sub-struts are different.

7. The vascular remodeling device of claim 5, wherein a length of the first one of the proximal sub-struts and a length of the second one of the proximal sub-struts are the same.

8. The vascular remodeling device of claim 1, wherein at least one proximal strut extends proximally from the intermediate portion and is divided into a first one and second one of the proximal sub-struts at or near the first waist of the proximal portion, the first one of the proximal sub-struts connected to a first adjacent strut and the second one of the proximal sub-struts connected to a second adjacent strut.

9. The vascular remodeling device of claim 8, wherein a length of the first one of the proximal sub-struts and a length of the second one of the proximal sub-struts are different.

10. The vascular remodeling device of claim 8, wherein a length of the first one of the proximal sub-struts and a length of the second one of the proximal sub-struts are the same.

11. The vascular remodeling device of claim 8, wherein the first and second adjacent struts extend proximally from the first waist of the proximal portion toward a radially central region of the device.

12. The vascular remodeling device of claim 1, wherein the distal struts extend longitudinally and radially inward from the first waist of the distal portion to form the distal face of the distal portion.

13. The vascular remodeling device of claim 12, wherein the distal struts forming the distal face have widened portions with increased cross-sectional widths that increase an occlusiveness of the distal face, wherein the widened portions of the distal struts are each wider than a width of at least one of a plurality of proximal struts forming a face, proximal to the first waist of the distal portion.

14. The vascular remodeling device of claim 13, wherein the widened portions of the distal struts each further comprise a first and second ramp, wherein the first ramp extends from an edge of the distal strut to an edge of the widened portion, and the second ramp extends from the edge of the widened portion to the edge of the distal strut.

15. The vascular remodeling device of claim 1, wherein the intermediate portion, the proximal portion, and the distal portion are all formed from a single sheet or tube of material.

16. The vascular remodeling device of claim 1, wherein:

the proximal portion forms a distal face located distal to the first waist of the proximal portion;

the distal portion forms a proximal face located proximal to the second waist of the distal portion; and

both the distal face of the proximal portion and the proximal face of the distal portion are less occlusive than the distal face of the distal portion.

17. The vascular remodeling device of claim 16, wherein the proximal portion forms a proximal face located proximal to the first waist of the proximal portion, and the proximal face of the proximal portion is less occlusive than the distal face of the distal portion.

18. The vascular remodeling device of claim 16, wherein the distal face of the proximal portion and the proximal face of the distal portion are configured such that they allow blood flow there through.

19. The vascular remodeling device of claim 1, wherein the distal face is configured to perform a therapeutic blocking function at an aneurysm, the function comprising at least one of (a) supporting maintenance of a therapeutically effective amount and/or density of at least one filling material in the aneurysm, (b) promoting thrombogenesis, and (c) diverting flow from the aneurysm.

20. The vascular remodeling device of claim 1, wherein a lumen of the intermediate portion is filled with a radiopaque material.

21. A vascular remodeling device, comprising:

a proximal portion sized for deployment in a blood vessel, the proximal portion having a longitudinal axis and being radially expandable from a collapsed state to an expanded state, the proximal portion having a first waist comprising a radially largest region of the proximal portion when in the expanded state;

a distal portion sized and configured for deployment at a junction of two or more blood vessels;

the distal portion being radially expandable from a collapsed state to an expanded state, the distal portion comprising a second waist configured to engage a wall of the junction when the distal portion is in its expanded state, the second waist comprising the radially largest region of the distal portion when the distal portion is in its expanded state;

the distal portion comprising, between a proximal end of the distal portion and the second waist, only a plurality of distal struts, the distal portion further comprising distal sub-struts that form a distal face located distal to the second waist, the distal face configured to face an aneurysm adjacent the junction when the second waist engages the wall and the distal portion is in its expanded state, wherein, distal to the second waist, (a) the distal struts each divide into at least two distal sub-struts wholly distal to the second waist; and

(b) distal to the second waist, the distal sub-struts each merge with an adjacent distal sub-strut, the distal portion having a total number of distal sub-struts that is double a total number of distal struts; and

an intermediate portion that couples the proximal portion and the distal portion;

wherein the proximal portion comprises a first plurality of interconnected proximal struts that extend distally from a proximal end of the proximal portion such that (a) proximal to the first waist, the proximal struts each (i) diverge from the longitudinal axis and (ii) divide into at least two proximal sub-struts; and

(b) distal to the first waist, the proximal sub-struts each (i) merge with an adjacent proximal sub-strut, and (ii) converge toward the longitudinal axis, the proximal portion having a total number of proximal sub-struts that is at least double a total number of proximal struts.

22. The vascular remodeling device of claim 21, wherein the distal face is configured to perform a therapeutic blocking function at the aneurysm, the function comprising at least one of (a) supporting maintenance of a therapeutically effective amount and/or density of at least one filling material in the aneurysm, (b) promoting thrombogenesis, and (c) diverting flow from the aneurysm.

23. The vascular remodeling device of claim 21, wherein the proximal sub-struts each merge with the adjacent proximal sub-strut to form a second plurality of proximal struts.

24. The vascular remodeling device of claim 23, wherein the number of the first plurality of proximal struts equals the number of the second plurality of proximal struts.

25. The vascular remodeling device of claim 23, wherein the number of the proximal sub-struts is double each of the number of the first plurality of proximal struts and the number of the second plurality of proximal struts.

26. The vascular remodeling device of claim 21, wherein the interconnected proximal struts are configured to maintain a three-dimensional shape of the proximal portion.

27. The vascular remodeling device of claim 21, wherein the interconnected proximal struts are configured to prevent the proximal struts from moving substantially toward a side of the blood vessel.

28. The vascular remodeling device of claim 21, wherein the interconnected proximal struts are configured to support each other structurally.

29. The vascular remodeling device of claim 21, wherein each proximal strut extends from an origination junction and is divided into a first one and second one of the proximal sub-struts, wherein the first one of the proximal sub-struts is connected to a first adjacent strut and the second one of the proximal sub-struts is connected to a second adjacent strut.

30. The vascular remodeling device of claim 21, wherein at least one proximal strut extends proximally from the intermediate portion and is divided into a first one and second one of the proximal sub-struts at or near the first waist, the first one of the proximal sub-struts connected to a first adjacent strut and the second one of the proximal sub-struts connected to a second adjacent strut.

31. The vascular remodeling device of claim 30, wherein a length of the first one of the proximal sub-struts and a length of the second one of the proximal sub-struts are different.

32. The vascular remodeling device of claim 30, wherein a length of the first one of the proximal sub-struts and a length of the second one of the proximal sub-struts are the same.

33. The vascular remodeling device of claim 30, wherein the first and second adjacent struts extend proximally from the first waist toward a radially central region of the vascular remodeling device.

34. The vascular remodeling device of claim 21, wherein the distal struts extend longitudinally and radially inward from the second waist to form the distal face of the distal portion.

35. The vascular remodeling device of claim 34, wherein the distal struts extend distally, from a proximal end of the distal portion, substantially along a distal portion longitudinal axis;

and wherein proximal to the second waist, the distal struts (i) diverge from the longitudinal axis and (ii) each divide into at least two distal sub-struts; and

wherein distal to the second waist, the distal sub-struts (i) merge with an adjacent strut, and (ii) converge toward the longitudinal axis.

36. The vascular remodeling device of claim 34, wherein the distal struts are configured to maintain a three dimensional shape of the distal portion.

37. The vascular remodeling device of claim 34, wherein the distal struts are configured to prevent the distal struts of the distal portion from moving to a side of the blood vessel.

38. The vascular remodeling device of claim 34, wherein the distal struts are configured to structurally support each other.

39. The vascular remodeling device of claim 21, wherein each distal strut extends from an origination junction and is divided into a first one and second one of the distal sub-struts, wherein the first one of the distal sub-struts is connected to a first adjacent distal strut and the second one of the distal sub-struts is connected to a second adjacent distal strut.

40. The vascular remodeling device of claim 21, wherein at least one distal strut extends distally from the intermediate portion and is divided into a first one and second one of the distal sub-struts at or near the second waist, the first one of the distal sub-struts connected to a first adjacent distal strut and the second one of the distal sub-struts connected to a second adjacent distal strut.

41. The vascular remodeling device of claim 21, wherein:

the proximal portion forms a distal face located distal to the first waist;

the distal portion forms a proximal face located proximal to the second waist; and

both the distal face of the proximal portion and the proximal face of the distal portion are less occlusive than the distal face of the distal portion.

42. The vascular remodeling device of claim 21, wherein a lumen of the intermediate portion is filled with a radiopaque material.